Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Screening Period | All participants that signed the consent. | 0 | None | 0 | 18 | 0 | 18 | View |
| Standard of Care | Evaluation and treatment of the participant's sleep disordered breathing will be per their participant's health care provider's usual care pathway. | 0 | None | 0 | 4 | 0 | 4 | View |
| Experimental: AVAPS-AE Non-invasive Ventilation Therapy | Participants will be initiated on AVAPS-AE therapy (intervention arm) for 60 days. AVAPS-AE is a mode of therapy (Philips Respironics Inc, Monroeville, Pa) with potential advantages over the currently established modes of non-invasive positive pressure ventilation (CPAP and bilevel therapy). This mode of therapy incorporates AVAPS (automated adjustable IPAP setting to maintain target ventilation with a settable rate of change), Auto EPAP and Auto Back up Rate. | 0 | None | 1 | 3 | 0 | 3 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hyperkalemia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Cardiac Arrhythmia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Acute Kidney Infection | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Fall secondary loss of consciousness | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |